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The effect of functional relaxation on the quality of life in patients with prosthetic joint infection - a randomized controlled trial

The effect of functional relaxation on the quality of life in patients with prosthetic joint infection - a randomized controlled trial - PROJECT

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
DRKS
Registry ID
DRKS00028881
Enrollment
270
Registered
2022-04-28
Start date
2022-10-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T84.5

Interventions

Group 1: 12 session functional relaxation a 45 minutes Group 2: 12 session of a unspecific placebo relaxation intervention a 45 minutes

Sponsors

Universitätsklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: Patients with verified prosthetic joint infection (PJI) aged 18 or older will be recruited. Written informed consent and surgical treatment including a one-staged exchange, or a two-staged exchange is a prerequisite for participation.

Exclusion criteria

Exclusion criteria: Patients diagnosed with a concomitant psychological disorder (ICD-10 F0-F9) or a Charlson-Comorbidity Index (CCI) > 3 will be excluded. Further, patients surgically treated with a debridement, antibiotics and implant retention (DAIR) approach or with an arthrodesis, as well as patients with a Girdlestone situation will be excluded.

Design outcomes

Primary

MeasureTime frame
Mental Component Summary (MCS) and Physical Component Summary (PCS) of quality of life assessed by the SF-36 health survey after 6 months.

Secondary

MeasureTime frame
SF-36 scores after 12 months, consumption of pain medication, mobility measured by the Parker mobility score and the physical activity measured by daily steps with an accelometer (actibelt®).

Countries

Germany

Contacts

Public ContactNike Walter

Universitätsklinikum RegensburgKlinik und Poliklinik für Unfallchirurgie

nike.walter@ukr.de09419446799

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 11, 2026